SI Joint Fusion and Decortication Using the SImmetry System

The purpose of the SI Joint Fusion and Decortication Using the SImmetry System study is to evaluate the SImmetry Sacroiliac Joint Fusion System for fusion of the SI joint and relief of SI joint pain symptoms.

Study Overview

• Status: Terminated
• Conditions: Sacroiliac Joint Dysfunction
• Intervention / Treatment: Device: SImmetry Sacroiliac Fusion System

Detailed Description

This is a prospective, non-randomized post market study designed to collect data on SI joint fusion and subject back pain following implant of the SImmetry device. The study will be conducted at a single site and 25 subjects will be implanted and followed through 24 months. Data will be collected pre-operatively, implant, and at specified follow-up time points through 24 months.

• Study Type: Observational
• Enrollment (Actual): 17

Contacts and Locations

Study Locations

• United States
  • Nevada
    • Reno, Nevada, United States, 89503
      • Reno Orthaepedic Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited from the Investigator's standard patient population diagnosed with SIJ pain and candidates for SIJ fusion.

Description

Inclusion Criteria:

• Subjects must be indicated for the SImmetry device according to the approved SImmetry labeling
• Subject has two (2) positive (experiences pain) Provocative Tests for SIJ pain; for example, Compression, Thigh Thrust, FABER, Distraction or Gaenslen's
• Subject has documentation of failed, non-operative management of SIJ pain for ≥ 6 months prior to surgery; for example, use of medications, braces, SI belts, orthotics, physical therapy or manual manipulation
• The subject has two (2) diagnostic SIJ injection at least one (1) resulting in a ≥50% decrease in pain in the joint(s) from the anesthetic portion of the injection
• The subject has VAS back pain score of ≥ 50 mm
• The subject is at least 18 years of age and skeletally mature
• The subject agrees and is able to comply with study requirements

Exclusion Criteria:

• Subjects contraindicated per the cleared labeling will be excluded from participation in the study
• The subject has pelvic soft tissue or bony tumors
• The subject has had any trauma causing fracture of the sacrum or iliac bones or has had spinal trauma leading to a neurological deficit
• The subject has a history of a central nervous system (CNS) disorder(s)
• The subject is indicated for or awaiting other spine surgery
• The subject is pregnant or is planning on becoming pregnant in the next two years
• The subject has uncontrolled insulin dependent diabetes mellitus (Type 1 Diabetes)
• The subject has chemical dependency abuse problems as evidenced by a history of abusing drugs which is documented in their past medical history or is elicited from an interview
• The subject is receiving or seeking worker's compensation, disability remuneration, and/or involved in litigation related to low back or SIJ pain
• The subject has a history of significant emotional or psychosocial disturbance (untreated or uncontrolled anxiety attacks, obsessive/compulsive disorders, depression or schizophrenia) as documented in their past medical history or elicited by an interview

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SI Joint Pain Reduction	SI joint pain reduction evaluated by use of Visual Analogue Scale (VAS) for back pain for comparison of baseline to 6 months.	6 months
SI Joint Fusion	Number of participants with radiographic evidence of fusion of the SI joint, defined as presence of a continuous segment of solid bridging bone that extends from the sacrum to the ilium.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SI Joint Pain Reduction	SI joint pain reduction evaluated by use of Visual Analogue Scale (VAS) for back pain for comparison of baseline to all follow-up visits.	24 Months

Collaborators and Investigators

• Sponsor: Zyga Technology, Inc.

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (ACTUAL): December 1, 2017
• Study Completion (ACTUAL): December 1, 2017

Study Registration Dates

• First Submitted: September 23, 2015
• First Submitted That Met QC Criteria: September 23, 2015
• First Posted (ESTIMATE): September 25, 2015

Study Record Updates

• Last Update Posted (ACTUAL): December 22, 2017
• Last Update Submitted That Met QC Criteria: December 20, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: sacroiliac joint fusion; SIJ Fusion; SI Joint; SIJ
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases; Ankylosis
• Other Study ID Numbers: 1099